Manual irrigation pump for intraprocedural irrigation

ABSTRACT

A disposable manual irrigation pump system comprises a manual foot pump operatively coupled to a fluid reservoir and an associated intraprocedural device. The pump system is configured to provide a substantially continuous fluid supply at a desired flow rate from the fluid reservoir to the associated intraprocedural device along a first direction without backflow of fluid along a direction opposite the first direction.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/781,487 filed May 17, 2010 now U.S. Pat. No. 8,231,574, which claimsthe benefit of U.S. Provisional Application No. 61/178,754 filed May 15,2009, which are hereby incorporated herein by reference.

FIELD OF INVENTION

The present invention relates generally to medical irrigation, and moreparticularly to a manual irrigation pump for intraprocedural irrigation.

BACKGROUND

During medical procedures when medical devices, such as an endoscope,are being used, oftentimes the physician performing the procedurerequires irrigation fluid to clean off a procedural area. Moreover,often the irrigation channel of the endoscope cannot provide therequired fluid.

To remedy this, the physician can use 60 cc syringes connected to anaccessory water channel of the endoscope. The physician can instruct anassistant to actuate the syringe thereby increasing the flow of thefluid. After the fluid in the syringe has been discharged, the assistantretrieves another syringe and repeats the process. In some instances, anelectrical or computer controlled pump may be used to eliminate some ofthe pitfalls of the 60 cc syringes by providing a continuous but lowflow stream of fluid.

SUMMARY OF INVENTION

Intraprocedural irrigation systems are used to provide more irrigationfluid to an intraprocedural device to clean off a procedure site duringthe procedure. Some intraprocedural irrigation systems suffer from notbeing able to provide a continual, high flow rate stream of irrigationfluid to the procedure site thereby limiting a physician's view duringendoscopic procedures. This is sometimes done so that the physician canbetter inspect or view (via an endoscope) patient's tissue. Thesedevices are cost prohibitive, and prevent the physician from devotingall of her attention to the patient.

A system, apparatus, and method provide a means for manually deliveringa fluid to an intraprocedural device, such as an endoscope, at acontinual high flow rate. More particularly, the system, apparatus, andmethod draws fluid from a reservoir and delivers the fluid into theendoscope through a series of liquid supply tubes. The intraproceduralirrigation system is targeted for situations requiring copious amountsof fluid such as poor preparations in the colon, gastrointestinalbleeds, undigested food in the stomach, bezoars, blood clot removal,etc.

Aspects of the disclosed technology relate to a system, apparatus, andmethod for a disposable manual irrigation pump system. A manual footpump is operatively coupled to a fluid reservoir and an associatedintraprocedural device. The pump system is configured to provide asubstantially continuous fluid supply at a desired flow rate from thefluid reservoir to the associated intraprocedural device along a firstdirection, without backflow of fluid along a direction opposite thefirst direction.

According to another embodiment, the disposable manual irrigation pumpsystem may include a first liquid supply tube disposed between the pumpand the reservoir and a second liquid supply tube disposed between thepump and the intraprocedural device.

According to another embodiment, the system further includes a connectorconfigured to couple an end of the first liquid supply tube and an endof the second liquid supply tube to the pump.

According to another embodiment, the system further includes a firstone-way valve disposed between the pump and the reservoir, wherein thefirst one-way valve allows fluid to flow from the reservoir to the pumpwithout backflow of fluid from the pump to the reservoir.

According to another embodiment, the system further includes a secondone-way valve disposed between the pump and the intraprocedural device,wherein the second one-way valve allows fluid to flow from the pump tothe intraprocedural device without backflow of fluid from theintraprocedural device to the pump.

According to another embodiment, the system further includes a caphaving threads suitable for coupling to a fluid reservoir having a firstdiameter and a stopper or second cap having threads suitable forcoupling to a fluid reservoir having a second diameter.

According to another embodiment, the cap further includes an air ventconfigured to allow air to flow into the fluid reservoir.

According to another embodiment, the system further includes a liquidsupply tube disposed in an opening of the cap.

According to another embodiment, the system further includes anirrigation valve configured to couple the intraprocedural device and thesecond liquid supply tube.

According to another embodiment, the system further includes a connectordisposed between the pump and the reservoir, wherein the connector isconfigured to insure the fluid flow is unimpeded through first liquidsupply tube.

According to another embodiment, the system further includes a thirdliquid supply tube disposed between the second liquid supply tube andthe irrigation valve, wherein the third liquid supply tube is configuredto couple the second liquid supply tube and the irrigation valve.

One aspect of the invention relates to a disposable irrigation pumpsystem configured to deliver irrigation fluid to an intraproceduraldevice, the system includes: a fluid reservoir containing an irrigationfluid; an elastically deformable pump operably connected to the fluidreservoir and the intraprocedural device and containing irrigation fluidwithin, wherein the elastically deformable pump is configured to propelfluid into the intraprocedural device upon deformation of the pump by anoperator; and a one way valve positioned between the pump and theintraprocedural device, the one way valve operably configured to providepassage of fluid from the pump to the intraprocedural device in responseto operator deformation of the elastically deformable pump, and furtherconfigured to prevent fluid movement from the intraprocedural device tothe pump upon release of the elastically deformable pump by theoperator.

According to another embodiment, the elastically deformable pumpincludes at least one hollow for the reception of fluid therein.

According to another embodiment, the elastically deformable pump isfurther configured to return to an un-deformed state upon release by theoperator.

Another aspect of the invention relates to a disposable irrigation pumpsystem configured to deliver irrigation fluid to an intraproceduraldevice, the system includes: a fluid reservoir containing an irrigationfluid; a one way valve positioned between the fluid reservoir and theintraprocedural device, the one way valve and operably configured toprovide passage of fluid from the fluid reservoir to the intraproceduraldevice and further configured to prevent to fluid passage from theintraprocedural device towards the fluid reservoir; and a pump operablyconfigured to provide a controlled flow rate of fluid to theintraprocedural device in direct response to a force applied onto thepump by an operator, wherein the flow rate from the disposableirrigation pump system is directly proportional to the force applied bythe operator.

According to another embodiment, a first rate of flow from the pump is adirect response to a first force applied to the pump by the operator.

According to another embodiment, when a second force is applied to thepump and the second force is greater than the first force, the rate offlow from the pump is greater than the first rate of flow.

According to another embodiment, when a third force is applied to thepump and the third force is less than the first force, the rate of flowfrom the pump is less than the first rate of flow.

According to another embodiment, the pump comprises a resilient materialand when force is removed from a deformed pump, the pump returns to anun-deformed shape and the one way valve prevents fluid from being drawninto the pump from the portion of the disposable irrigation pump systembetween the one way valve and the intraprocedural device.

To the accomplishment of the foregoing and related ends, the invention,then, comprises the features hereinafter fully described andparticularly pointed out in the claims. The following description andthe annexed drawings set forth in detail certain illustrativeembodiments of the invention. These embodiments are indicative, however,of but a few of the various ways in which the principles of theinvention may be employed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an environmental view of an exemplary intraproceduralirrigation system in accordance with the invention.

FIG. 2 is a perspective view of an exemplary manual irrigation pumpsystem in accordance with the invention.

FIGS. 3A-3D are a top view, front view, perspective view and side view,respectively of an exemplary cap.

FIGS. 4A-4C are a top view, front view and side view, respectively of anexemplary manual foot pump.

FIG. 5 is a perspective view of an exemplary irrigation biopsy valve.

FIGS. 6A-6D are a cross-sectional view, side view, perspective view anda front view, respectively of an exemplary one-way valve.

FIG. 7 is a perspective view of another manual irrigation pump system inaccordance with the invention.

FIG. 8 is a perspective view of another irrigation biopsy valve.

FIG. 9 is a perspective view of yet another manual irrigation pumpsystem in accordance with the invention.

FIG. 10 is a perspective view of yet another irrigation biopsy valve.

DETAILED DESCRIPTION

A physician performing a procedure often requires more irrigation fluidto clean off a procedural area then the irrigation channel of theendoscope can deliver. 60 cc syringes can be used to provide moreirrigation fluid, but the use of 60 cc syringes is time consuming,awkward and leads to procedural delays. Syringes can leak at the biopsyvalve thereby occupying the time of both the physician and assistants.This takes the physicians full attention away from the procedure. Theuse of the electrical pump devices can eliminate some of the problemsassociated with the 60 cc syringes, but the devices are unnecessarilycomplicated, and still do not provide sufficient volume, pressure andspeed through the accessory channel of the endoscope to sufficientlyclean tissue for a full inspection/viewing. These devices are costly(especially to have in every procedure room at a hospital or anoutpatient office) and become even more costly when maintenance andrepair of the devices are taken into account. Additionally, when thedevices are receiving maintenance and repair, the physician is leftwithout access to continual irrigation, leaving the physician with thesame problems that the expensive machine was purchased to prevent.

A further problem resulting from the use of these alternative fluidsupply devices is that the devices need to be reprocessed. According tothe Society of Gastroenterology Nurses and Associates, water supplies,connectors and tubing should be manually cleaned and disinfected orsterilized on a daily basis. Therefore, the caps, tubing or other partsof the 60 cc syringes or pump systems need to be reprocessed beforebeing used again. This reprocessing can be both costly and timeconsuming, can lead to delays between procedures, and does not offereach patient a new sterile product that has never been reprocessed.

As an alternative to the syringes and electrical pumps, certain pumpsystems that provide fluid from an I.V. bag are known in the art. U.S.Patent Application Publication 2005/0025646 to Miller et al. discloses amedical irrigation system. Fluid flows from I.V. bags down into an inletvalve of a pump thereby filling the pump with fluid. When the pump isactuated, the fluid flows out the outlet valve, and to a device such asan endoscope. This device relies solely on gravity to provide the fluidfrom the I.V. bags and is a less than optimal solution because thesystem must be disposed of or reprocessed/resterilized after each use.

U.S. Pat. No. 5,505,707 to Manzie et al. discloses a hand pumpirrigation system. A continual low flow stream of fluid flows from I.V.bags, down through a pump and into a medical instrument. When aphysician requires more fluid, a bolus of fluid can be delivered fromthe pump. This device also relies on gravity to provide the fluid fromthe I.V. bags and suffers from the whole system needing disposed of orreprocessed after one use. Additionally, this system actually prevents acontinual high flow stream of fluid from entering the medical instrumentbecause after the bolus of fluid is delivered from the pre-filled pump,and while the pump is refilling, fluid is still flowing to the medicalinstrument at the initial low flow rate. This continual low flow streamof fluid slows the refill of the pump and prevents a continual high flowstream from being delivered to the medical instrument. Even if thesystem could provide a continual high flow stream of fluid, the systemoccupies one of the physician's hands during use, making it impossiblefor the physician to operate the system while performing the procedure.

The disclosed technology recognizes the shortcomings with conventionalirrigation systems, and provides a solution that allows a physician toprovide a fluid to an intraprocedural device, such as an endoscope,ureteroscope, hysteroscope, etc., throughout an entire day's worth ofprocedures. This is accomplished while also allowing the physician tocontrol the flow rate of the fluid. The manual irrigation pump isdesigned to give the physician optimum control of the flow rate andvolume of irrigation fluid during the procedure. The system provides animmediate response when the physician engages the device by stepping onthe pump and disengages the device by removing his/her foot. The manualfoot pump thereby allows an assistant to attend to the needs of thepatient and other requests from the physician without having to worryabout supplying irrigation.

The principles of the invention will now be described with reference tothe drawings. Referring to FIG. 1, an environmental view of an exemplarymanual irrigation system 10 in accordance with the invention is shown.Manual irrigation system 10 operably couples to a medical instrument orintraprocedural device 48 to dispense irrigation fluids therefrom, andcomprises a manual irrigation pump system 50 operably connected to abiopsy valve 38. The system 10 couples or otherwise connects to a waterbottle 12 or other fluid reservoir that contains a fluid. A liquidsupply tube 24 is coupled to a cap 14, or formed integrally with the cap14, and placed in fluidic communication with the fluid in the waterbottle 12 via another liquid supply tube 22. The other end of the liquidsupply tube 24 is coupled to a connector 28. The connector 28 is alsocoupled to a manual foot pump 30 and a liquid supply tube 32. The liquidsupply tube 24 delivers the fluid from the water bottle 12 to the manualfoot pump 30 when the pump 30 is actuated, and the pump 30, in turn,delivers the fluid to the liquid supply tube 32. The liquid supply tube32 is also coupled to biopsy valve 38, via fittings 36 and 40 (or thelike), and the biopsy valve 38 is coupled to an intraprocedural device48 by valve fitting 46. The fluid flows through the liquid supply tube32, through the biopsy valve 38 and to the intraprocedural device 48 forirrigating the procedure site. The fluid source may be elevated todecrease fill time of the pump 30, however it will be appreciated thatelevation of the fluid source is not required.

In this manner, the physician is able to provide a fluid to a proceduresite while being able to control the flow rate and volume of the fluid.When the physician is finished with the procedure, the biopsy valve 38can be disposed of and a new biopsy valve can be inserted in its place.Then, another procedure can be performed using manual irrigation pumpsystem 50, described in more detail below, and the new biopsy valve 38.By following this procedure, the manual irrigation pump system 50 may bereused for multiple procedures while advantageously providing a newsterile biopsy valve 38 for every patient.

Referring now to FIGS. 1 and 2, the manual irrigation pump system 50 isdescribed. The manual irrigation pump system 50 couples to a fluidsource, represented as water bottle 12, which contains a fluid. Althoughdescribed using the water bottle 12 as the fluid container, the fluidsource may be any number of fluid sources such as an I.V. bag, areservoir, etc. The water bottle 12 can be a reusable water bottle or adisposable water bottle, and the opening of the water bottle can be ofvarying diameters. To accommodate water bottles 12 with varying openingdiameters, the system 50 includes the cap 14 having threads configuredto couple to a water bottle 12 with a first opening diameter, and astopper 16, or second cap having threads, disposed in the cap 14configured to couple to a water bottle 12 of varying opening diametersthat are less than the first diameter. For example, the cap may bedesigned to fit a water bottle with an opening of 2.5 inches.

During the procedure, when the cap 14 is coupled to the water bottle, ifthe water bottle has an opening diameter of 2.5 inches, then the cap 14is threaded onto the bottle and the procedure can begin. If during theprocedure the liquid in the water bottle 12 runs out, and the new waterbottle has an opening diameter less than 2.5 inches (or the water bottleinitially used has an opening diameter less than 2.5 inches), then thestopper 16 is coupled to the opening of the new water bottle and theprocedure may continue. When the stopper 16 and the cap 14 are coupledto the water bottle 12, a sealed connection between the water bottle 12and the system 50 is created, preventing fluid from leaking. In apreferred embodiment, a polypropylene cap having a liner, manufacturedby United States Plastic Corp., may be used as cap 14.

The cap 14 also includes an air vent 18 configured to allow air to flowfrom the atmosphere to the water bottle 12. In at least one embodimentdescribed below, the vent 18 can counteract pressure increases ordecreases that occur in the water bottle when the pump system 50 isbeing used. Additionally, an antimicrobial filter (not shown) can bedisposed in the cap 14 or water bottle 12 to ensure that there is nobacterial contamination in the water bottle 12, resulting from theintroduction of ambient air into the bottle. And, if desired, anoptional seal 15 (not shown) can be provided to seal between the cap 14and the bottle 12. FIGS. 3A-3D provide further illustrations and somedetails of cap 14 described above, including the threaded portion of thecap, represented by reference numeral 58 and a through opening 17 may beprovided to allow access to the fluids within bottle 12. The figuresshow a top view, front view, perspective view and side view,respectively of cap 14. The cross-section A-A, which is labeled in FIG.3A, is shown in FIG. 3D.

Coupled to the cap 14 is the liquid supply tube 22, which places the cap14 in fluidic communication with the fluid. A one-way valve 20 can beprovided, as shown in FIG. 2, and may be located at the top of theliquid supply tube 22, in-between the cap 14 and the supply tube 22. Theone-way valve 20 is used to limit the direction of fluid flow and caninclude a check-valve, a poppet valve, etc. The one-way valve 20 isoriented so that it restricts fluid flow so that the fluid flow is inthe direction from the water bottle 12 toward the liquid supply tube 24and not from the liquid supply tube 24 back toward the water bottle 12.In another embodiment, the valve 20 may be located at the bottom of thesupply tube 22, which may help anchor the tube to the bottom of thewater bottle 12, thereby minimizing the water left in the water bottle12. In still another embodiment, the one-way valve 20 can be locatedbetween the cap 14 and liquid supply tube 24 (or disposed in the cap orliquid supply tube 24), used to couple the liquid supply tube 24 withthe cap 14.

With continued reference to FIG. 2, the supply tube 24 can have aproximal end that is coupled to the cap 14 and a distal end that iscoupled to one of the openings in connector 28. The supply tube 24 maybe coupled to the cap 14 by a fitting, a one-way valve described in FIG.6, etc. or may have a fitting integrated into its design. Alternatively,the liquid supply tube 24 may run through the cap and replace liquidsupply tube 22 or be integrally formed with the cap 14, and thereforenot require a fitting to couple with the cap 14.

Disposed in or otherwise operatively coupled to the liquid supply tube24 is an optional one-way valve 26, oriented so that it restricts fluidflow so the fluid flow is in the direction from the pump 30 toward theliquid supply tube 32 and not from the pump 30 back toward the liquidsupply tube 24. This prevents fluid expelled from the pump 30 fromflowing back to the first liquid supply tube 24 thereby hindering thefluid flow to the biopsy valve 38. The one-way valve 26 may include acheck-valve, a poppet valve, etc., and, in addition to being disposed inthe liquid supply tube 24, the valve 26 may also be disposed in a firstopening of connector 28 that couples the connector 28 to liquid supplytube 24. As mentioned above, one-way valve 26 is an optional valve.One-way valve 20, which may be configured in any location between thesupply tube 22 and the pump 30, may be used to as the only valve toprevent fluid flow from the pump 30 to the water bottle 12.

Coupled to a second opening of the connector 28 is the liquid supplytube 32. The liquid supply tube 32 has a proximal end coupled to theconnector 28, and a distal end operatively coupled to or having anintegrated fitting 36. The fitting 36 is used to releasably couple theliquid supply tube 32 to the removable and replaceable biopsy valve 38via fitting 40 on the biopsy valve 38. In this example, the fitting 36on liquid supply tube 32 is a luer lock-type fitting, but the fitting 36may be any type of fitting such as a hose barb, a hose coupler, etc.Optionally included on liquid supply tube 32 is a pinch clamp 34, whichcan be used to stop the fluid flow into the biopsy valve 38 at any time.Also optionally included in the liquid supply tube 32 is anotheroptional one-way valve (not shown). The optional one-way valve can beused in place of the pinch clamp 34, although the valve and clamp 34 canbe used in conjunction with one another. The optional one-way valve canbe used to prevent the fluid from flowing into the biopsy valve 38 andtowards the intraprocedural device 48 below a certain system pressure.For example, if the pressure needed to open the optional one-way valveis normally 3 psi above atmospheric pressure when the pump is actuated,then a 3 psi check valve may be used for the optional one-way valve toprevent fluid flow at less than 3 psi when a pressure of less than 3 psiis applied to the pump. When the physician or operator needs toimmediately stop fluid flow, he/she removes his/her foot from the pump30, but some fluid will already be in liquid supply tube 32 flowingtoward the intraprocedural device 48. Because the physician is no longeractuating the pump 30, the fluid in the tube will be flowing at lessthan 3 psi, and therefore because of the 3 psi check valve the fluidwill not enter the intraprocedural device 48. The 3 psi check valve canalso allow a system pressure below about 3 psi to be maintained withinthe portions of the manual irrigation pump system 50 proximal to orupstream to the 3 psi check valve. In some embodiments, air vent 18 canbe used to bleed down the system pressure caused by the 3 psi checkvalve.

Referring now to the connector 28 in more detail, the connector 28 asshown is a y-connector used to bifurcate the flow of fluid in and out ofpump 30. The connector can be made from any suitable material. Althougha y-connector is shown, other types of connections may be used as longas the connection bifurcates the fluid flow. A first opening of theconnector 28 is coupled to liquid supply tube 24, a second opening iscoupled to liquid supply tube 32 and a third opening is coupled to thepump 30. Using the connector 28, the pump 30 is only required to haveone opening 54, thereby simplifying construction and decreasing chancesof leaking or other problems associated with fluid pumps having multipleopenings. Further, by using connector 28 with pump 30, the liquid supplytubes 24 and 32 can be located to prevent the physician from gettingtangled in the tubes 24 and 32 or from accidentally stepping on thetubes 24 and 32 and interrupting fluid flow.

Referring now to manual foot pump 30 in more detail, FIGS. 4A-4C providea top view, front view and side view, respectively of the manual footpump 30 which can include one or more hollows or chambers (see dashedlines in FIG. 4) within operably coupled to opening 54. The chamber ofthe pump 30 is represented by reference numeral 52 and can occupy asubstantial portion of the interior of the pump 30. When the pump 30 isactuated such as by compressing the pump 30 to decrease the volume ofthe chamber 52, the pump body physically deflects or elastically deformsand fluid is delivered from the pump 30 to the intraprocedural device 48via opening 54. Pump 30 can be constructed from an elastomeric orresilient material that can be deformed under a force such as but notlimited to foot pressure, yet generally return to an un-deformed shapeshown in FIGS. 4A-4C upon removal of the force or pressure. The materialproperties of the pump 30 can be further configured to providesufficient force to draw fluid into the chamber 30 as the pump 30 movesfrom the deformed shape to the un-deformed shape.

The actuation of the pump 30 requires an operator (such as a surgeon) tophysically deliver mechanical work to the pump 30 to pressurize themanual irrigation pump system 50. Mechanical work requires the surgeonor operator to apply a physical force over a distance and it is themechanical work or energy delivered by the physical action of theoperator over the distance that provides the energy to pressurize system50 and to propel fluid into the intraprocedural device 48.

For example, but not limited thereto, the physical force can be apressure applied to the pump 30 with a foot, a hand, or an elbow tocreate the motive pressure on fluid contained therein. With pump 30, theforce input is directly proportional to the pump pressure and fluid flowfrom the pump 30. That is, more force on the pump 30 equates to higherpump pressures and more flow, and less force on the pump 30 equates tolower pump pressures and less flow. Thus, any input of arcuate or linearforce physically applied over distance by any portion of an operator'sanatomy is a manual transfer of mechanical work from the operator to thepump 30 to propel an amount of fluid from the manual irrigation pumpsystem 50. Since the operator provides the mechanical work, the operatorcan easily control of the flow rate and volume of irrigation fluidduring a procedure. Should the operator deplete or empty the fluid fromthe chamber 52 from a sustained application of pressure, the chamber 52can be refilled by simply removing the operator's contact from the pump30 and allowing the pump 30 to return to the un-deformed shape.

As is discussed above, one-way valve 20 and optional one-way valve 26limit the direction in which the fluid can flow. The pump 30 includes abase 56 or other support, which allows the pump 30 to sit flat againstthe floor or other surface to prevent the pump 30 from changingpositions during the procedure. When the physician removes his or herfoot, thereby releasing the pump 30, the fluid is drawn from the waterbottle 12 into chamber 52 via opening 54. The volume and flow rate offluid is dictated by the pressure and duration of pulses provided by thephysician.

The quick refill time, along with other features of the system 50,allows the physician to control the pressure, volume, and flow rate ofthe water. Before each procedure, the pump 30 can be primed to removeair from the system 50 and allow the physician to have immediate accessto irrigation. In a preferred embodiment, a pump such as onemanufactured by Albert International may be used. Although the pump 30is described as a foot pump, other types of manual pumps may be usedsuch as hand operated pumps, spring operated foot pedals, etc.Additionally, although the pump 30 is described having only one opening,a pump with a first opening for the first liquid supply tube 24 and asecond opening for the second liquid supply tube 32 may be used. In thedual opening pump example, a connector is not required to place theparts in fluidic communication, although one may be used.

Referring now to FIG. 5, a perspective view of exemplary irrigationbiopsy valve 38 is shown. The biopsy valve 38 includes a fitting 40, aone-way valve 42, a liquid supply tube 44, and a valve fitting 46. Theliquid supply tube 44 of biopsy valve 38 has a proximal end that isintegrally coupled to the fitting 40, and a distal end that isintegrally coupled to the valve fitting 46. The irrigation valve 46removably couples to an accessory water channel of the intraproceduraldevice 48, allowing the biopsy valve 38 to be easily attached anddetached from the accessory channel of the intraprocedural device 48 andpreventing leakage around the accessory channel. If desired, the biopsyvalve 38 may have an opening for insertion of other devices into theaccessory channel. Valve fitting 46 can be constructed from a flexibleor elastomeric material such as but not limited to rubber, urethane, orsilicone. In one embodiment, a valve cap 49 is provided. The valve cap49 can be configured to lock with the valve fitting 46, and can be usedto seal the top portion of the valve fitting 46. In some embodiments,valve cap 49 can be integrally attached to the valve fitting 46 or anintegral portion thereof. Valve fitting 46 can be constructed from aflexible or elastomeric material described above, or configured as anintegral part of valve fitting 46, and the integrally attached valve cap49 can be flexibly deflected into locking engagement with valve fitting46.

In an alternate embodiment, the valve cap 49 can be secured to the topportion of the valve fitting 46 by an alternate securing systemcomprising one or more securing members 90 (not shown). The one or moresecuring members 90 are configured to engage with one or more featureson valve fitting 46 and/or the intraprocedural device 48 to hold thevalve cap 49 in sealing engagement with the valve fitting 46. The one ormore features on valve fitting 46 can be as shown, or can be or a memberor feature added to an exterior of the valve fitting 46 such as a rib, asnap, a detent, and the like. In another embodiment, but not limitedthereto, the securing members 90 can be an integral portion of the valvefitting 46 and can be flexibly deflected to securely engage withfeatures on valve fitting 46 and/or the intraprocedural device 48 tohold the valve cap 49 in sealing engagement with valve fitting 46. Thefitting 40 is used to removably couple the biopsy valve 38 to thefitting 36 of the liquid supply tube 32. In this example, the fitting 40is a luer lock-type fitting. If the fitting 36 is a male luer lock-typefitting then the fitting 40 can be a female luer lock-type fitting orthe reverse. Other fittings may be used, however, such as hose barbs,hose couplers, etc. Above the fitting 40, or alternatively disposed inthe fitting 40, is a one-way valve 42. The one-way valve 42 is orientedso that it restricts fluid flow so the fluid flow is in the directionfrom the fitting 40 toward the liquid supply tube 44 and not from theliquid supply tube 44 back toward liquid supply tube 32. The one-wayvalve 42 prevents fluid in the biopsy valve 38 from flowing back towardliquid supply tube 32 and confines the backflow fluids to the portion ofthe biopsy valve 38 located between the valve fitting 46 and the one-wayvalve 42 . This allows the pump system 50 to be used for multipleprocedures while only having to dispose the biopsy valve 38 to provideeach new patient with sterile parts and sterile fluids, and withoutreprocessed components.

Referring to FIGS. 6A-6D, a cross-sectional view, side view, perspectiveview and a front view, respectively of an exemplary one-way valve 60 isshown. FIG. 6A shows a partial cross-sectional view of the valve 60,taken from section B-B, which along with direction of the flow, islabeled in FIG. 6B. The one-way valve 60 may be used as valves 20, 26,or 42 described above, although other valves may be used, such as valvesbeing disposed in the liquid supply tubes or connectors. Valve 60 has afirst end 62 and a second end 64 configured and sized for insertion intothe liquid supply tubes and other parts. For example, using valve 60 asone-way valve 20, the first end 62 of the valve 60 can be inserted intothe stopper 16/cap 14, and the second end 64 of the valve 60 can beinserted into the liquid supply tube 24. The valve places the two partsin fluidic communication with one another and prevents fluid fromflowing back into the water bottle 12. One-way valves are well known inthe art, can include springs or other pressure control devices, and in apreferred embodiment, a precision molded check valve with a siliconediaphragm, manufactured by Ark-Plas Products, Inc., may be used.

Turning now to FIGS. 7 and 8, another embodiment of manual irrigationpump system and irrigation biopsy valve is indicated generally byreference numerals 150 and 138, respectively. The pump system 150 andbiopsy valve 138 are substantially the same as the above-described pumpsystem 50 and biopsy valve 38, and consequently the same referencenumerals, but indexed by 100 are used to denote structures correspondingto similar structures in the pump system 50 and biopsy valve 38. Inaddition, the foregoing description is equally applicable to the pumpsystem 150 and biopsy valve 138 except as noted below. The pump systems50 and 150 and biopsy valves 38 and 138 can be used in any combinationbased on the desired application.

Referring to FIG. 7, the manual irrigation pump system 150 is shown. Thepump system 150 includes an optional one-way valve 126, disposed in orotherwise operatively coupled to the liquid supply tube 124, andoriented so that it restricts fluid flow so the fluid flow is in thedirection from the pump 130 toward the liquid supply tube 132 and notfrom the pump 130 back toward the liquid supply tube 124. The pumpsystem 150 also includes another one-way valve 142 that replaces or canbe used in conjunction with the pinch clamp shown in FIG. 2. The one-wayvalve 142 is disposed in or otherwise operatively coupled to the liquidsupply tube 132 and is oriented so that it restricts fluid flow so thefluid flow is in the direction from the liquid supply tube 132 towardthe biopsy valve 138 and not from the biopsy valve 138 back toward thepump 130. A fitting 136 is also located at a distal end of the liquidsupply tube 132 and configured to operably and removably engage with thebiopsy valve 138. Referring now to FIG. 8, the irrigation biopsy valve138 is shown. Included on the biopsy valve 138 is a pinch clamp 134 thatreplaces or can be used in conjunction with the one-way valve shown inFIG. 5. The pinch clamp 134 can be used by the operator to stop thefluid flow through the liquid supply tube 144 at any time, and can beopened to resume fluid flow at any time. A one-way valve 140 can also beprovided with the liquid supply tube 144, and is shown adjacent to aproximal end of the tube 144 to prevent backflow into the liquid supplytube 132. A valve cap 149 and valve fitting 146 can be attached to adistal end of the liquid supply tube 144, and can perform the samefunctions as the previously described valve cap 49 and valve fitting 46,respectively. Turning now to FIGS. 9 and 10, another embodiment ofmanual irrigation pump system and irrigation biopsy valve is indicatedgenerally by reference numerals 250 and 238, respectively. The pumpsystem 250 and biopsy valve 238 are substantially the same as theabove-described pump system 50 and biopsy valve 38, and consequently thesame reference numerals, but indexed by 200 are used to denotestructures corresponding to similar structures in the pump system 50 andbiopsy valve 38. In addition, the foregoing description is equallyapplicable to the pump system 250 and biopsy valve 238 except as notedbelow. The pump systems 50, 150 and 250 and biopsy valves 38, 138 and238 can be used together in any combination based on the desiredapplication.

Referring now to FIG. 9, the manual irrigation pump system 250 is shown.The pump system 250 includes a one-way valve 220, which is located abovethe cap 214, in-between the cap 214 and connector 270. The one-way valve220 is oriented so that it restricts fluid flow so that the fluid flowis in the direction from the water bottle 212 toward the liquid supplytube 224 and not from the liquid supply tube 224 back toward the waterbottle 212. In another embodiment, the valve 220 may be located at thebottom of the supply tube 222, which may help anchor the tube to thebottom of the water bottle 212, thereby minimizing the water left in thewater bottle 212. In still another embodiment, the one-way valve 220 canbe located at the top of the liquid supply tube 222, in-between the cap214 and the supply tube 222 (or disposed in the cap or liquid supplytube 224).

With continued reference to FIG. 9, the supply tube 224 has a proximalend that is coupled to the connector 270 and a distal end that iscoupled to one of the openings in connector 228. The supply tube 224 maybe coupled to the connector 270 by a fitting, be integrated with theconnector 270, etc., or may have a fitting integrated into its design.The connector 270, which can have one end coupled to the supply tube 224and another end coupled to the one-way valve 220, is provided to preventthe supply tube 224 from bending, kinking, etc. during use, therebyinsuring that the fluid can flow through the supply tube 224.

Coupled to a second opening of the connector 228 is the liquid supplytube 232. The liquid supply tube 232 has a proximal end coupled to theconnector 228, and a distal end coupled to or having an integratedfitting 236. The fitting 236 is used to couple the liquid supply tube232 to the biopsy valve 238 via fitting 240 or to couple a liquid supplytube 272 to the liquid supply tube 232 via fitting 278. In this example,the fittings are luer lock-type fittings, but the fittings may be anytype of fitting such as a hose barb, a hose coupler, etc. Included onliquid supply tube 232 is a pinch clamp 234, which can be used to startor stop the fluid flow into the biopsy valve 238 at any time.

Also included in the pump system 250 is a coupler 274. The coupler 274may be configured to releasably retain supply tube 272 to and supplytube 232 together, thereby allowing easy access to supply tube 272. Ifdesired by the operator, the supply tube 272 may be coupled to thesupply tube 232 and the biopsy valve 238 via fittings 278 and 276,respectively. The supply tube 272 can have a one-way valve 226 disposedin or coupled to supply tube 272, which can be used to prevent the fluidfrom flowing into the biopsy valve 238 below a certain pressure.

Referring now to FIG. 10, a perspective view of irrigation biopsy valve238 is shown. The biopsy valve 238 includes a fitting 240, a one-wayvalve 242, liquid supply tubes 244 and 280, a valve fitting 246, and apinch clamp 282. The liquid supply tube 280 has a proximal end that iscoupled to the fitting 240, and a distal end that is coupled to theone-way valve 242. The liquid supply tube 244 has a proximal end that iscoupled to the one-way valve 242 and a distal end that is coupled to thevalve fitting 246 which is shown with a valve cap 249 removably sealingan opening in valve fitting 246. It will be appreciated that the one-wayvalve 242 may be disposed in one of the supply tubes 244 or 280 or thatthe biopsy valve 238 may include only one supply tube. The one-way valve242 is oriented so that it restricts fluid flow so the fluid flow is inthe direction from the liquid supply tube 280 toward the liquid supplytube 244 and not from the liquid supply tube 244 back toward liquidsupply tube 232.

Included on one of the supply tubes 244 or 280 is pinch clamp 282, whichcan be used by the operator to stop or start the fluid flow through theliquid supply tube 244 or 280 at any time. Included at one end of thebiopsy valve 238 is the irrigation valve fitting 246 configured tocouple to an accessory water channel of the intraprocedural device (notshown), allowing the biopsy valve 238 to be easily attached and detachedfrom the accessory channel of the intraprocedural device (not shown) andpreventing leakage around the accessory channel. If desired, the biopsyvalve 38 may have an opening for insertion of other devices into theaccessory channel. In one embodiment, a valve cap 49 is provided. Thevalve cap 49 can be used to seal the top portion of the valve fitting 46and could also have device access.

At the other end of the biopsy valve 238 is the fitting 240, configuredto couple the biopsy valve 238 to the fitting 236 or 276 of the liquidsupply tube 232. In this example, the fitting 240 is a luer lock-typefitting. If the fitting 236 or 276 is a male luer lock-type fitting,then the fitting 240 can be a female luer lock-type fitting or thereverse. Other fittings may be used, however, such as hose barbs, hosecouplers, etc.

Although the invention has been shown and described with respect to acertain embodiment or embodiments, it is obvious that equivalentalterations and modifications will occur to others skilled in the artupon the reading and understanding of this specification and the annexeddrawings. In particular regard to the various functions performed by theabove described elements (components, assemblies, devices, compositions,etc.), the terms (including a reference to a “means”) used to describesuch elements are intended to correspond, unless otherwise indicated, toany element which performs the specified function of the describedelement (i.e., that is functionally equivalent), even though notstructurally equivalent to the disclosed structure which performs thefunction in the herein illustrated exemplary embodiment or embodimentsof the invention. In addition, while a particular feature of theinvention may have been described above with respect to only one or moreof several illustrated embodiments, such feature may be combined withone or more other features of the other embodiments, as may be desiredand advantageous for any given or particular application.

What is claimed is:
 1. A disposable manual irrigation pump systemcomprising: a manual foot pump configured to be coupled to a fluidreservoir and an intraprocedural device; a first supply tube disposedbetween the pump and the reservoir; a second supply tube disposedbetween the pump and the intraprocedural device; a Y-connectorconfigured to be coupled to an end of the first supply tube, an end ofthe second supply tube, and the pump; a biopsy valve having a first endcoupled to the second supply tube and a second end configured to becoupled to the intraprocedural device; an irrigation valve coupled tothe second end of the biopsy valve; and a third supply tube disposedbetween the second supply tube and the irrigation valve, wherein thethird supply tube is configured to couple the second supply tube and theirrigation valve.
 2. The disposable irrigation pump system of claim 1,wherein the Y-connector has an opening configured to be coupled to thefirst supply tube, an opening configured to be coupled to the secondsupply tube, and an opening configured to be coupled to the pump.
 3. Thedisposable manual irrigation pump system of claim 1, wherein the pumpincludes a single opening, the single opening being connected to theY-connector.
 4. The disposable manual irrigation pump system of claim 1,further comprising a first one-way valve disposed between the foot pumpand the reservoir, the one-way valve being configured to allow fluid toflow from the reservoir to the pump without backflow of fluid from thepump to the reservoir.
 5. The disposable manual irrigation pump systemof claim 4, further comprising a second one-way valve disposed betweenthe pump and the intraprocedural device, the second one-way valve beingconfigured to allow fluid to flow from the pump to the intraproceduraldevice without backflow of fluid from the intraprocedural device to thepump.
 6. The disposable manual irrigation pump system of claim 1,further comprising a cap having threads suitable for coupling to a fluidreservoir.
 7. The disposable manual irrigation pump system of claim 6,wherein the cap further includes an air vent configured to allow air toflow into the fluid reservoir.
 8. The disposable manual irrigation pumpsystem of claim 1, further comprising a connector disposed between thepump and the reservoir, the connector being configured to prevent thefirst supply tube from bending or kinking.
 9. The disposable manualirrigation pump system of claim 1, further comprising a fluid reservoircontaining an irrigation fluid, wherein the pump is operably connectedto the fluid reservoir and the intraprocedural device and containsirrigation fluid within, wherein the pump is configured to propel fluidinto the intraprocedural device upon deformation of the pump by anoperator.
 10. The disposable manual irrigation pump system of claim 9,wherein the manual foot pump includes at least one opening for thereception of fluid therein.
 11. The disposable manual pump system ofclaim 9, wherein the manual foot pump is further configured to return tothe un-deformed state upon release by the operator.
 12. The disposablemanual irrigation pump system of claim 1, further comprising a fluidreservoir containing an irrigation fluid, wherein the manual foot pumpis operably configured to provide a controlled flow rate of fluid to theintraprocedural device in direct response to a force applied onto thepump by an operator.
 13. The disposable irrigation pump system of claim12, wherein a first rate of flow from the pump is a direct response to afirst force applied to the pump by the operator.
 14. The disposableirrigation pump system of claim 13, wherein when a second force isapplied to the pump and the second force is greater than the firstforce, the rate of flow from the pump is greater than the first rate offlow.
 15. The disposable irrigation pump system of claim 14, whereinwhen a third force is applied to the pump and the third force is lessthan the first force, the rate of flow from the pump is less than thefirst rate of flow.
 16. The disposable manual irrigation pump systemaccording to claim 1, further comprising a coupler, wherein the coupleris configured to retain the second and third supply tubes.